Cleared Traditional

Watch-PAT200U (K153070) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153070 · Itamar Medical , Ltd. · Anesthesiology device
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Jul 2016
Decision
278d
Days
Class 2
Risk

K153070 is an FDA 510(k) clearance for the Watch-PAT200U. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 26, 2016 after a review of 278 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Itamar Medical , Ltd. devices

Submission Details

510(k) Number K153070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date July 26, 2016
Days to Decision 278 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 140d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 54
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K153070.
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K181996 · Zephyr Sleep Technologies · Nov 2018
Watch-PAT300
K180775 · Itamar Medical , Ltd. · Aug 2018
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SOMNOLYZER 24X7
K131994 · Respironics, Inc. · Oct 2013
STARDUST II
K052573 · Respironics, Inc. · Dec 2005
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004